Literature DB >> 22032264

Results from the single-use autoinjector for self-administration of subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis (MOSAIC) study.

Sibyl Wray1, Robert Armstrong, Craig Herrman, Jonathan Calkwood, Mark Cascione, Eric Watsky, Brooke Hayward, Brian Mercer, Fernando Dangond.   

Abstract

BACKGROUND: Patients with multiple sclerosis (MS) often receive long-term injectable therapy, and difficulties associated with self-injection can affect treatment adherence and efficacy.
OBJECTIVE: The objective of this study was to evaluate an investigational, ready-to-use, single-use autoinjector for self-injection of subcutaneous (sc) interferon beta-1a (IFNβ-1a).
METHODS: In this multicenter, open-label, single-arm study, patients with relapsing MS who were receiving IFNβ-1a sc 44 μg three times weekly for ≥ 12 weeks continued therapy using a single-use autoinjector and completed a user trial questionnaire at baseline and weeks 6 and 12. The primary endpoint was the proportion of patients rating the autoinjector as easy or very easy to use at week 12.
RESULTS: At 12 weeks, 86% of 109 patients included in the intent-to-treat population rated the autoinjector easy or very easy to use (95% confidence interval, 80% - 93%), and the most important perceived benefit was its overall convenience. The majority (74%) of patients reported the device as somewhat or extremely convenient to use, and most (83%) agreed or strongly agreed that the device made injections simple.
CONCLUSION: The single-use autoinjector was well received and supported by favorable ratings for simplified injections and convenience. The results suggest that the device may improve overall injection experience in patients with relapsing MS.

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Year:  2011        PMID: 22032264     DOI: 10.1517/17425247.2011.628656

Source DB:  PubMed          Journal:  Expert Opin Drug Deliv        ISSN: 1742-5247            Impact factor:   6.648


  6 in total

1.  Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population.

Authors:  Jakob Lange; Philipp Richard; Nick Bradley
Journal:  Med Devices (Auckl)       Date:  2015-06-03

2.  ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.

Authors:  Gabriel Boeru; Ivan Milanov; Francesca De Robertis; Wojciech Kozubski; Michael Lang; Sònia Rojas-Farreras; Mark Tomlinson
Journal:  Med Devices (Auckl)       Date:  2013-11-15

Review 3.  Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics.

Authors:  Zhaoyang Li; Rachael Easton
Journal:  MAbs       Date:  2017-11-07       Impact factor: 5.857

4.  Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis.

Authors:  Florence Schwarzenbach; Michèle Dao Trong; Laurent Grange; Philippe E Laurent; Herve Abry; Joël Cotten; Corinne Granger
Journal:  Patient Prefer Adherence       Date:  2014-02-11       Impact factor: 2.711

5.  Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study).

Authors:  Elena Didenko Pedersen; Egon Stenager; J L Vadgaard; M B Jensen; R Schmid; N Meland; G Magnussen; Jette L Frederiksen
Journal:  Patient Prefer Adherence       Date:  2018-04-19       Impact factor: 2.711

Review 6.  A Systematic Review of Patients' Perspectives on the Subcutaneous Route of Medication Administration.

Authors:  Colin H Ridyard; Dalia M M Dawoud; Lorna V Tuersley; Dyfrig A Hughes
Journal:  Patient       Date:  2016-08       Impact factor: 3.883

  6 in total

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